A Prospective Study of Variation in Breath Holding Times at Various Phases of Respiration During the Course of Radiotherapy Including the Effect of Respiratory Training in Lung Cancer Patients

Sponsor

Tata Memorial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01429766

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

100 suitable patients of lung cancer shall be taken into the study over a period of 2 years. As per the existing treatment protocol in our department, all patients suitable shall undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall be done at the following times

At time of simulation
At the time of first fraction of radiotherapy
At mid radiotherapy
At radiotherapy conclusion After the recording at a), patients shall be asked to perform deep breathing exercises/spirometer ball exercise to see the effect of training on the breath holding times.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer Non Small Cell Lung Cancer	Other: Respiratory Training	Phase 2

Detailed Description

At time of simulation
At the time of first fraction of radiotherapy
At mid radiotherapy
At radiotherapy conclusion After the recording at a), patients shall be asked to perform deep breathing exercises/spirometer ball exercise to see the effect of training on the breath holding times.

Respiratory training All patients shall be sent for respiratory training to the physiotherapy department. Patients shall be counseled about respiratory training by trained staff in their own vernacular. Whenever possible, patients shall be provided one "Spiroball" device and taught how to use the device. In addition/alternatively patients will be taught to do breath exercises. Patients provided with spiroball shall be instructed to use the spiroball by the prescribed technique. The following visit schedule shall be observed

st visit Within one day of the date of simulation
nd visit Date of Radiotherapy starting Subsequently 2 visits per week during radiotherapy course shall be conducted (Tuesdays, Thursdays) During all the above visits , respiratory training shall be reinforced and objective recording of the spirometer ball(whenever used) shall be recorded.(Inspiratory volume)

The breathing exercises shall continue through radiotherapy. At all the above times, recording shall be made of the breath holding times. In general at the start of each recording a nasal clip shall be placed and the patient shall be asked to close the mouth voluntarily. The closure of the mouth shall be done after nasal clip placement and then stopwatch for recording shall be started. The end time shall be the moment when the patient opens his mouth and starts breathing again. A one minute pause shall be kept between separate recordings.

Deep inspiratory breath hold(DIBH): A clip shall be placed on the nose. The patient shall be asked to take a deep breath from his mouth and then hold his breath.
Deep expiratory breath hold(DEBH): A clip shall be placed on the nose. The patient shall be asked to exhale maximally from the mouth and then hold his breath.
Normal mid ventilation breath hold(NVBH): A clip shall be placed on the nose. The patient shall be asked to hold breath in the middle of normal respiration.

Beam on/off times As mentioned before, all the patients shall be treated as per existing departmental protocol. However, as a planning component of the study, after the patients have been planned as per the routine protocol, the breath hold data in each phase shall be used to calculate the number of times the radiation beam would have to be needed if patients were treated with the above breath hold timings.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Prospective Study of Variation in Breath Holding Times at Various Phases of Respiration During the Course of Radiotherapy Including the Effect of Respiratory Training in Lung Cancer Patients

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

May 1, 2012

Anticipated Study Completion Date :

May 1, 2012

Outcome Measures

Primary Outcome Measures

Breath holding time in various phases of the respiratory cycle [2 years]
Breath holding time in deep inspiration, mid ventilation and end expiration

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of Small cell and Non small cell lung cancer
Patients posted for 3DCRT or IMRT or IGRT

Exclusion Criteria:

Patients, who in view of their advanced disease and/or poor general condition would not be able to tolerate radical RT.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tata Memorial Hospital	Mumbai	Maharashtra	India	400012

Sponsors and Collaborators

Tata Memorial Hospital

Investigators

Principal Investigator: Anusheel Munshi, MD, Tata Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anusheel Munshi, Associate Professor, Tata Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01429766

Other Study ID Numbers:

First Posted:

Sep 7, 2011

Last Update Posted:

Sep 7, 2011

Last Verified:

Sep 1, 2011

Keywords provided by Anusheel Munshi, Associate Professor, Tata Memorial Hospital

Breath holding times

Phases of respiration

Radiotherapy

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Study Results

No Results Posted as of Sep 7, 2011